FDA grants clearance to Philips’ new digital pathology solution

17 April 2017 (Last Updated April 17th, 2017 18:30)

The US Food and Drug Administration (FDA) has granted regulatory clearance to Royal Philips' new digital pathology system 'IntelliSite Pathology Solution' for primary diagnostic use.

FDA grants clearance to Philips’ new digital pathology solution

The US Food and Drug Administration (FDA) has granted regulatory clearance to Royal Philips' new digital pathology system 'IntelliSite Pathology Solution' for primary diagnostic use.

The new pathology system is designed to assist pathologists in viewing and diagnosing digital images of surgical pathology slides.

The automated digital pathology image creation, viewing and management solution features a rapid pathology slide scanner, a display and an image management system.

IntelliSite system is accompanied by advanced software tools for managing the scanning, storage, presentation, reviewing and sharing of information.

"Not only will it promote increased efficiencies and collaboration between pathologists, but it also opens a completely new dimension towards computational pathology which aims to increase accuracies and ultimately enhance patient care."

Philips Digital Pathology Solutions general manager Russ Granzow said: "The clearance for Philips IntelliSite Pathology Solution marks a major milestone for innovation in pathology services in the US.

"Not only will it promote increased efficiencies and collaboration between pathologists, but it also opens a completely new dimension towards computational pathology, which aims to increase accuracies and ultimately enhance patient care."

Digital pathology is expected to streamline workflow and extend collaboration in order to minimise pressure on pathology services, as well as boost diagnostic confidence.

The FDA clearance is based on data from the clinical study of surgical pathology cases conducted at Cleveland Clinic, University of Virginia, Miraca Life Sciences and Advanced Pathology Associates.

The study compared the use of digital pathology to optical microscopes in around 2,000 cases.

Based in the Netherlands, Royal Philips includes diagnostic imaging, image-guided therapy, patient monitoring and health informatics.

With operations in more than 100 countries, the firm has reported sales of €17.4bn last year.


Image: Philips receives FDA clearance to market Philips IntelliSite Pathology Solution for primary diagnostic use in the US. Photo: courtesy of PRNewsFoto/Royal Philips.